DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14, line 6, “lever” should be “level”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite, for example line 2 of claim 14, “sorafenib or donafenib at a molecular level”. It is unclear what “at a molecular level” means, given the claim already requires the compounds per se.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 14, 17, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma et al (Drug Delivery and translational Research, Vol 10, 2020, 2190-3948).
Sharma et al discloses a type III self-emulsifying delivery system of sorafenib tosylate, wherein a stable microemulsion is prepared by means of selecting lipids, emulsifiers, etc., and a polymer of HPMC-E5 and PVP-K25 (1: 1) is used as a precipitation inhibitor to further supersaturate and improve the long-term stability of the drug, and pharmacokinetic parameters are significantly improved (abstract, page 840, left-hand column, paragraphs 1 and 2, page 843, left-hand column, paragraph 1, page 849, left-hand column, last paragraph, and page 858, right-hand column, paragraph 1). In addition, it is used for treating cancers including hepatocellular carcinoma, kidney cancer and thyroid cancer.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-33 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al (Drug Delivery and translational Research, Vol 10, 2020, 2190-3948) in view of CN 107115317 (CN ‘317).
Sharma et al is discussed above but does not teach the various poilymer combnmation.
CN ‘317 teaches a pharmaceutical composition comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix-forming component, and optionally at least one pharmaccutically acceptable solubilizer, wherein the polymeric stabilizing and matrix-forming component is selected from hydroxypropyl methylcellulose phthalate, polyvinylpyrrolidone, polyvinyl acetate phthalate, copovidone, crospovidone, methacrylic acid and ethylacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, polycthylene glycol, cellulose acctate phthalate, etc. (see description, paragraphs [0013], [0015], [0019], [0032]-[0065] and [0214]-[0216], and table 26) When the inhibitor is sorafenib, the polymeric stabilizing and matrix forming component is hydroxypropyl methylcellulose phthalate, and the solubilizer is polyvinylcaprolactam-polyvinyl. acetate-polyethylene glycol copolymer. The composition has an increased dissolution rate compared to the inhibitor in raw crystalline form. The composition is administered orally, etc., in the form of a pharmaccutically acceptable dosage form, such as a capsule or tablet. The drug can be used for treating cancers such as breast cancer, rectal cancer and colon cancer.
It would have been obvious to one of ordinary skill in the art to vary the composition of the polymer maxtrix of Sharma et al as taught by CN ‘317. In doing so, it would be obvious to optimize the amount of polymer and active to provide stability and efficacy for the condition to be treated, here the various cancers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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